Ephedrine Sulfate

Product NDC: 16714-037
11-digit product format: 167140037
Labeler code: 16714
Product ID: 16714-037_ab525532-8541-49b9-ba78-c39ebdc4c60d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ephedrine Sulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: NorthStar Rx LLC
Application: ANDA212932
Marketing category: ANDA
Marketing start: 2020-12-02
Substance: EPHEDRINE SULFATE
Active strength: 50 mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-037	16714-037-25	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212932-001	EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP		2019-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212932-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212932-001	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION / INTRAVENOUS	AP	2019-10-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212932-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212932-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212932-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212932-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212932-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212932-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212932-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212932-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212932-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212932-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212932-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212932-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212932-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212932-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212932-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212932-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212932-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212932-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212932-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212932-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212932-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212932-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212932-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212932-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212932-001	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212932-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212932-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212932-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212932-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212932-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212932-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212932-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212932-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212932-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212932-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212932-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212932-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212932-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212932-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ephedrine Sulfate	EPHEDRINE SULFATE	NorthStar Rx LLC	7b29542f-3a32-4113-bb1c-1fbd280046e2	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932 ndc (product): 16714-037
Ephedrine Sulfate	EPHEDRINE SULFATE	Amneal Pharmaceuticals LLC	765ed48b-b381-418a-9847-068f7f4cc838	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	d163ff39-d1a4-b61f-e053-2995a90ab6d5	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932
Ephedrine Sulfate	EPHEDRINE SULFATE	Medical Purchasing Solutions, LLC	c8e8ec0e-988b-85a1-e053-2a95a90a2268	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212932 application number: ANDA212932

Additional Listing Data#

Finished product: Yes
Brand name base: Ephedrine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPHEDRINE SULFATE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U6X61U5ZEG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116294	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7b29542f-3a32-4113-bb1c-1fbd280046e2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3d	Product name	2	20251211
f1d178e1-1663-4c63-ae37-62a1b322fba4	Product name	2	20251106
f606d3ac-dd63-4b29-bea0-db23753b8ddc	Product name	1	20220118
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
30254138-2d98-4aa2-8e07-ae82e8b0a389	Product name	3	20171103
fee762de-ffd9-404d-8bc6-8c0c208e758d	Product name	1	20170426
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16714-037-01	Ephedrine Sulfate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION	1	8
16714-037-10	Ephedrine Sulfate	10 in 1 CARTON	INJECTION	10	8
16714-037-25	Ephedrine Sulfate	25 in 1 CARTON	INJECTION	25	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-037-01	ML - Milliliter	16714-037	5eeafb9b-27eb-44c6-a9b2-d18579ee9b52	1	2021-11-09
16714-037-10	ML - Milliliter	16714-037	80d30f89-2063-49fe-963f-05c6f584ae40	1	2021-11-09
16714-037-25	ML - Milliliter	16714-037	aebf152c-e9d1-4720-97ef-65c8dec06ebf	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-037	EPHEDRINE SULFATE INJECTION [NORTHSTAR RX LLC]	8	Current NDC, Legacy NDC, 3 package rows	20250130_7b29542f-3a32-4113-bb1c-1fbd280046e2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U6X61U5ZEG	EPHEDRINE SULFATE	134-72-5	EPHEDRINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1116294	ePHEDrine sulfate 50 MG in 1 ML Injection	PSN	7b29542f-3a32-4113-bb1c-1fbd280046e2	8
1116294	1 ML ephedrine sulfate 50 MG/ML Injection	SCD	7b29542f-3a32-4113-bb1c-1fbd280046e2	8
1116294	ephedrine sulfate 50 MG per 1 ML Injection	SY	7b29542f-3a32-4113-bb1c-1fbd280046e2	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-037-01	16714003701	1 mL in 1 VIAL, SINGLE-DOSE	1 ml					Historical
16714-037-10	16714003710	10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10) / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01)		2020-12-02	0000-00-00	No	No	Current
16714-037-25	16714003725	25 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-25) > 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01)		2020-12-02	0000-00-00	No	No	Current